# K163379: KneeAlign 2 System

- Pathway: 510(k) (Traditional)
- Applicant: Orthalign, Inc.
- Decided: Mar 2, 2017 after 91 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K983831 (1999). 40 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103829: Kneealign System, Orthalign, Inc. (2011) Summary page 4.
- K153237: OrthAlign Plus System, Orthalign, Inc. (2016) Summary page 4.

## Most influential descendants
- K192653: Perseus (2020), 0 descendants of its own

## Indications for use
The KneeAlign® system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopedic surgical procedures. The KneeAlign system facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes. Orthopedic surgical procedures include but are not limited to: * Total Knee Arthroplasty * Unicompartmental Knee Arthroplasty — Tibial Transverse Resection

Source page: https://510kreport.com/device/K163379
Methodology: https://510kreport.com/methodology